Diphenoxylate Hydrochloride And Atropine Sulfate
NDC Package 70166-630-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diphenoxylate Hydrochloride And Atropine Sulfate is effective as adjunctive therapy in the management of diarrhea. Marketed by Lohxa, this product is identified by NDC 70166-630 and is authorized under FDA application ANDA087708.

Identification & Billing

NDC Package Code
70166-630-01
Package Description
12 BAG in 1 BOX / 1 SYRINGE in 1 BAG / 5 mL in 1 SYRINGE
Product Code
70166-630
11-Digit Billing Format
70166063001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Dosage Form
-
Usage Information
Diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea.

Regulatory & Marketing

Labeler Name
Lohxa
FDA Application #
ANDA087708
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-03-1982
Listing Expiration
12-31-2022
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70166-630-01 identifies a specific commercial package of 12 bag in 1 box / 1 syringe in 1 bag / 5 ml in 1 syringe of Diphenoxylate Hydrochloride And Atropine Sulfate, labeled by Lohxa. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lohxa on May 03, 1982. The current certification is valid through December 31, 2022.

How is this Lohxa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70166063001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70166-630-01
11-Digit CMS (5-4-2)
70166-0630-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.